Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance
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Purpose
This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Other patients' tumors are drug-resistant from the start. The study will look for "resistance factors"-substances in blood and tissues that render tumors resistant to chemotherapy. The findings may provide information needed to develop methods of combating drug resistance.
Patients with cancer who are 18 years or older may be eligible for this study. Participants will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study; additional samples will be obtained periodically during the course of treatment. A small sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor biopsy (removal of a small piece of tumor) for medical reasons or as part of a research treatment protocol. Patients who do not require surgery or biopsy may be asked permission to obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1) withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen; 3) removing a small tumor sample through a needle; or 4) removing the sample with a small incision into or around the tumor. These procedures will be done only if they are of low risk to the patient.
| Condition |
|---|
|
Neoplasm |
| Study Type: | Observational |
| Official Title: | Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
- Patients 18 years of age and older are eligible.
- Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
- Patients with malignancy are eligible.
- Patients requiring a surgical procedure for any medical indication can be included on study.
- Patients requiring biopsy or any procedure for any medical indication can be included on study.
- Patients not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, or peritoneal fluid, or biopsy samples, providing the biopsy or aspiration procedure is of minimal risk, i.e. fine needle aspirate, bone marrow aspirate, or excisional biopsy. No radiology tests will be used in the procedure to collect a sample that would not be otherwise used for an appropriate medical indication.
- Normal volunteers 18 years of age and older are eligible to enroll. Normal volunteers must be willing to sign informed consent and must be willing to provide samples to be used for research.
EXCLUSION CRITERIA:
- Pregnant individuals will not be eligible due to potential risks to the fetus associated with radiologic procedures required for biopsy.
- Children will not be eligible because of potential risks from complications due to procedures involved in obtaining the biopsies.
- Normal volunteers with a history of a clotting disorder may not enroll.
Contacts and Locations| Contact: Robin R. Eisch, R.N. | (301) 402-5958 | fryer@mail.nih.gov |
| Contact: Susan E Bates, M.D. | (301) 402-0984 | sebates@helix.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
| Principal Investigator: | Susan E Bates, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00026663 History of Changes |
| Obsolete Identifiers: | NCT00919529 |
| Other Study ID Numbers: | 000078, 00-C-0078 |
| Study First Received: | November 14, 2001 |
| Last Updated: | May 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Resistance Malignant Biopsy Samples Specimen Acquisition Cancer Cells |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013